Criteria for the recognition of the authorization of research protocols issued by a Foreign Regulatory Authority are published

May 19th 2025

• In accordance with the General Health Law, the Ministry of Health (the “SSA”) is responsible for coordinating research on human beings, which may be authorized for preventive, rehabilitative or research purposes, even when there is insufficient scientific evidence of its therapeutic efficacy or when the therapeutic indications of already known products are intended to be modified. 
• Furthermore, the Law states that the Federal Commission for the Protection against Sanitary Risks (“COFEPRIS”) is responsible for the evaluation, issuance and revocation of authorizations in health matters, as well as acts of authority for the regulation, control and promotion of health. 
• Under this premise, since January 4, 2013, it was published in the Official Gazette of the Federation (“DOF”), the Mexican Official Standard NOM-012-SSA3-2012 that establishes the regulatory criteria of an administrative, ethical and methodological nature for the authorization, execution and monitoring of projects and protocols for research purposes for the use of medicines or materials in human beings.
• However, in an effort to modernize the current regulation to the current conditions of the pharmaceutical market, on March 24, 2025, the same SSA published, in the DOF, the Agreement establishing the criteria for the authorization of research protocols in human subjects that have been previously authorized by a foreign regulatory authority (he "Agreement”), providing for the procedure of “Reliance".

GENERAL CONTENT

The purpose of the Agreement is to establish the list of Foreign Regulatory Authorities (“ARE”) and the criteria for the recognition of the authorization of research protocols issued by an ARE, through the procedure based on trusted regulatory practices, that is, the “Reliance”, as well as the criteria for carrying out such authorization, solely for research on human beings.

It is called "Reliance” the act by which a public institution or body authorized to exercise independent regulatory oversight over the development, production, market authorization and surveillance of medical products within its jurisdiction, called the National Regulatory Authority (“RNA”), takes into account and gives considerable weight to the evaluations carried out by another regulatory authority or reliable institution ARE, resulting in a work of simplification and updating of efforts that allow optimizing resources and reducing costs and management times.[1] regarding research protocols for a new molecule or a new use of an existing drug.

Acceptance of international standards must be based on evidence that the authorizations issued by the ARE have undergone a full and independent review by that authority, and that the ARE's requirements are sufficient to meet the regulatory requirements of the NRA, which will remain responsible for the decisions taken and will be held accountable.

Applications must be submitted through the COFEPRIS platform for procedures and services (“DIGIPRiS”). In addition to the normal requirements for submitting applications, a certified, legalized or apostilled copy with a Spanish translation of the clinical protocol issued by the ARE is required. This copy must have been issued no more than one year ago, along with an English copy of the Protocol and Investigator's Manual, with which the authorization to conduct the clinical protocol was obtained, and the Spanish version approved by the respective committees in Mexico.

Finally, the Agreement indicates that COFEPRIS will consider decisions based on regulatory practices of Reliance of the European Medicines Agency (“EMA”), the United States Food and Drug Administration (“FDA”), the Medicines and Healthcare Products Regulatory Agency (“MHRA”) of the United Kingdom and the Canadian Health Agency (“Health Canada”), and will be empowered to deny authorization of the research protocol in the event of sufficient evidence of a lack of safety, quality, efficacy, purity or stability of the Protocol or of serious risks to the research subjects. 

TRANSITORY

• The Agreement will enter into force 60 business days after the date of its publication in the DOF, that is, on Thursday, June 19, 2025.

We are at your disposal for any information related to the impact or scope of the publication of the Agreement on the Recognition of Research Protocol Authorization.

[1] Federal Commission for the Protection against Sanitary Risks. (2021). Case study: Reliance, COFEPRIS, and the international arena.